NCT04312737

Evaluation of in Vitro Devices on Self-collected Vaginal Swab and Urine Sample for Testing of Human Papilloma Virus

European VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples and Urine Samples

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Hiantis Srl · Industry
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: —

Summary

The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection device is as accurate to detect cervical pre-cancer as on cliniciantaken cervical samples.

Detailed description

Women accessing the Colposcopy Centres for a colposcopy examination and fulfilling the selection criteria will be asked, after written informed consent, to self-collect a first-void urine (with the Colli-Pee device) and a vaginal sample (with the FLOQSwab device), prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also take a cervical sample (with a Cervex-Brush using the same procedure normally adopted for cervical cytology and/or HPV testing. During colposcopy, a colposcopy-targeted biopsy may be taken if appropriate. When according to colposcopy and biopsy results, an excisional treatment of a cervical precancer lesion is needed, the histology of the excised tissue will complete the end point of the study. The colposcopy and histological findings will be used as the gold standard if biopsies are taken. In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will provide the study outcome. Three new PCR-based HPV 'in vitro diagnostic devices' (Papilloplex, HPV Oncopredict RNA, HPV Oncopredict DNA) developed as part of the SME Instrument Project 'HPV OncoPredict (GA-806551)' will be assessed.

Conditions

• Cervical Intraepithelial Neoplasia Grade 2/3
• Neoplasm Cervix
• Carcinoma in Situ
• Carcinoma Cervix Uterine
• Neoplasms
• Neoplasms by Histologic Type

Interventions

Type	Name	Description
DEVICE	Self-Collecting Devices	FLOQSwab (Copan) Colli-Pee (Novosanis)
DIAGNOSTIC_TEST	In Vitro Diagnostic Assays	Papilloplex (GeneFirst) HPV Oncopredict DNA (Hiantis) HPV Oncopredict RNA (GeneFirst)

Timeline

• Start date: 2020-07-16
• Primary completion: 2022-02-23
• Completion: 2022-03-15
• First posted: 2020-03-18
• Last updated: 2023-01-06

Locations

6 sites across 3 countries: Ireland, Italy, United Kingdom

Regulatory

• FDA-regulated device study